Important update! The implementation of the PMPRB amended guidelines will be delayed to July 1, 2021, from the original date of January 1, 2021. Read more: http://yhoo.it/38O5xDm
This page will be updated shortly with new information.
WHAT IS THE PMPRB?
The Patented Medicines Price Review Board (PMPRB) is an independent, quasi-judicial body that regulates the maximum amount that companies can charge for their medicines in Canada. This is done at the point of entrance for a drug in Canada.The PMPRB has a mandate to protect Canadian consumers by ensuring that the prices of patented medications are not excessive.
When a drug comes to Canada it must go through the Canadian drug regulatory, review and reimbursement system. The drug must go to various review bodies before it is eligible for public reimbursement. It must first be approved by Health Canada for safety, efficacy, and quality, then goes to the PMPRB.
One of Cystic Fibrosis Canada’s key advocacy priorities is for a regulatory and reimbursement environment in Canada that does not unnecessarily limit our access to existing and new life-saving therapies. Please visit our Trikafta Can't Wait page to find out how you can get involved.
HOW IS THE PMPRB IMPACTING ACCESS TO CF MEDICATIONS?
In May of 2017, Health Canada proposed changes to the Patented Medicines Prices Review Board (PMPRB) regulations. These changes incorporate new factors in determining whether a medicine is being or has been sold at an “excessive” price.
Since the changes to the Patented Medicines Regulations were first proposed, the patient community has consistently raised concerns that these changes will negatively impact access to new medicines for Canadian patients.
The new PMPRB regulations require patented drug manufacturers to significantly reduce their prices. By some estimates, these changes will require reductions in price as high as 75%, but the actual reductions depend on a number of assumptions that themselves are creating uncertainty. Upon implementation, Canada will become an outlier among OECD countries and a much less attractive market in which to launch innovative therapies, including precision medicines that can alter the course of devastating diseases like cystic fibrosis.
The impact of these regulatory changes:
November 1, 2019 to February 29, 2020 Health Canada registration of new clinical trials decreased by 60% compared with the average of four years prior.
Moreover, “between 2015 and 2018, 49 per cent of new drugs were approved in Canada either prior to or within a year of their approval in the United States. In 2019, the rate fell to just 15.6 per cent. That’s a drop of more than two-thirds.” - Nigel Rawson, & John Adams, Price controls imposed by shortsighted politicians keep new life-saving drugs out Financial Post March 2020.
The PMPRB, and the federal government, have repeatedly assured patient groups that access to new medicines will not be impacted by the proposed regulatory changes.
CF CANADA’S STANCE ON THE CHANGES TO THE PMPRB GUIDELINES
On February 14, 2020, Cystic Fibrosis Canada called on the federal government to halt implementation of regulatory changes to the PMPRB.
Changes to the comparator countries used by the PMPRB are deemed acceptable, but changes aimed at further reducing prices are creating an uncomfortable uncertainty and could make Canada an outlier amongst OECD countries, and a less desirable destination for drug manufacturers. They put access to game-changing medicines like Trikafta at risk and should be evaluated by an independent third party to avoid unintended negative consequences to patients.
On June 19, 2020,the Government of Canada released updated draft guidelines to the regulations of the PMPRB. The PMPRB commented they had received nearly 900 letters from members of the CF community in an advocacy initiative spearheaded by CF Canada.
While Cystic Fibrosis Canada welcomed the revisions to the draft guidelines and supports pricing controls as a means to improve accessibility, these PMPRB guidelines have gone too far and could continue to create an environment that discourages manufacturers from bringing life-changing CF medicines to Canada. There are some provisions in the guidelines that could be promising for Trikafta, but we aren’t confident they are good enough.
RECOMMENDATION 1: As a commitment to lowering drug costs to reasonable levels, Cystic Fibrosis Canada urges the PMPRB to take a phased approach to implementation, and begin with implementation of the changes to the comparator countries. All other changes aimed at further reducing prices should be put on hold until the PMPRB can learn about the impact of implementing phase one, and until the impact of the new economic criteria can be thoroughly evaluated by an independent third party.
RECOMMENDATION 2: As a commitment to improving access to innovative medicines for Canadians who need them now, Cystic Fibrosis Canada calls on the PMPRB to immediately amend the Health Canada approval deadline for Gap Medicines to an application deadline. Under this amendment, manufacturers would have until January 2nd, 2021 to apply for a Drug Identification Number (DIN), rather than secure a DIN by that time as currently outlined in the guidelines.
RECOMMENDATION 3: Cystic Fibrosis Canada recommends that an independent third party evaluate the impact of the revised economic criteria on the availability of medicines in Canada specifically to inform any decision on whether, when and how to implement the use of the new economic criteria for innovative, precision and other high cost medicines. Until this is completed and the value of these measures is demonstrated, no such measures should be adopted.
RECOMMENDATION 4: Cystic Fibrosis Canada calls on the federal government to require that the PMPRB, along with other appropriate agencies, immediately establish a formal mechanism for meaningfully and continuously engaging patient representatives in its decision-making and processes to ensure patient voice, choice and representation. Patient Advisory Councils aimed at improving access for themselves and others are utilized in many of Canada’s comparator countries. Now that the PMPRB will be weighing in on the economic value of patient lives, patients need to be at the table to weigh in on the value of their lives too.
The CF community sent the PMPRB over 1,850 letters supporting Cystic Fibrosis Canada's submission on the revised PMPRB guidelines.
On Thursday, July 30, 2020 , Cystic Fibrosis Canada held a Q&A webinar session hosted by Dr. John Wallenburg, Chief Scientific Officer, and Kim Steele, Director, Government and Community Relations, for Cystic Fibrosis Canada. The webinar focused on the PMPRB, our response to the revised draft guidelines and what they might mean for access to life-changing CF medications.
Watch the recording:
On October 23, 2020, the PMPRB released their final version of the revised guidelines. We are disappointed that the new guidelines do not appear to have factored in any of Cystic Fibrosis Canada’s recommendations that were submitted during the guidelines consultation process, nor do they keep patient voices at the centre. While the new guidelines do recognize that an evaluation process is needed for the future, the details are vague and don’t outline the inclusion of patients. We continue to call on the government to revisit these guidelines and find a needed balance between lower drug prices and access to innovative medicines remains lacking.
On Monday 26 October 2020, the House of Commons Standing Committee on Health (HESA), a committee responsible for the oversight of Canadian health issues, voted to support a motion for further consultations on the PMPRB guidelines conducted by the HESA committee.
Cystic Fibrosis Canada provided a written submission to the first part of the study’s consultation process. We worked closely alongside CF Get Loud, CF Treatment Society and the Canadian Organisation for Rare Disorders (CORD) to align our messages with the CF and rare disease community. We have also requested to present at the committee hearings which are due to take place before committee members before the end of the year.
Webinar series | Trikafta : How to advocate for access
Join us on March 4th to learn more about the canadian political environment and how you can advocate for access to Trikafta. In this webinar, an expert from Hill & Knowlton in the drug-approval political environment will explain Trikafta’s position in the system and the road ahead before the treatment is in the hands of those who need it.